CLAFORAN - PWS INJ 1.0G/VIAL POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEFOTAXIME SODIUM

Disponibil de la:

SANOFI-AVENTIS CANADA INC

Codul ATC:

J01DD01

INN (nume internaţional):

CEFOTAXIME

Dozare:

1G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CEFOTAXIME SODIUM 1G

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

IM:3.4ML/IV:10.4ML/IV INF.:53.4ML TO 1010.4ML; 10XIG

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THIRD GENERATION CEPHALOSPORINS

Rezumat produs:

Active ingredient group (AIG) number: 0152507001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2017-11-24

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
CLAFORAN
®
Cefotaxime for injection, Mfr. Std.
1g and 2g cefotaxime (as cefotaxime sodium) per vial
β-lactam Antibiotic
sanofi-aventis Canada Inc.
2905 Place Louis-R-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
November 12, 2014
Submission Control No.: 176886
s-a Version dated
2
PRODUCT MONOGRAPH
PR
CLAFORAN
®
Cefotaxime for injection, Mfr. Std.
1g and 2g cefotaxime (as cefotaxime sodium) per vial
β-lactam Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
CLAFORAN (cefotaxime for injection) is a semi-synthetic,
2-aminothiazolyl cephalosporin
antibiotic for parenteral use. _In vitro _studies indicate that the
antibacterial action of CLAFORAN
results from inhibition of cell wall synthesis. It is stable against
the action of most β-lactamases.
INDICATIONS AND CLINICAL USE
TREATMENT
_ _
_ _
CLAFORAN (cefotaxime for injection) may be indicated for the treatment
of infections caused
by susceptible strains of the designated micro-organisms in the
diseases listed below.
LOWER RESPIRATORY TRACT INFECTIONS:
Pneumonia
and
lung
abscess
caused
by
_Streptococcus _
_pneumoniae_
(formerly
_Diplococcus_
_pneumoniae_), other streptococci (excluding enterococci, e.g. _S.
faecalis_),_ Staphylococcus_ _aureus_
(penicillinase
and
non-penicillinase
producing),_ _
_Escherichia _
_coli_,_ _
_Hemophilus _
_influenzae_,
(including ampicillin resistant strains) and unspecified _Klebsiella_
species.
URINARY TRACT INFECTIONS:
Caused by _Escherichia coli_, unspecified _Klebsiella_ species
(including _K. pneumoniae_),_ Proteus_
_mirabilis_, indole positive _ Proteus_, _ Serratia marcescens_ and _
Staphylococcus epidermidis_. Also,
uncomplicated gonorrhea caused by _N. gonorrhoeae_ including
penicillin resistant strains.
BACTEREMIA/SEPTICEMIA:
Caused by _Escherichia coli_, unspecified _Klebsiella_ strains and
_Serratia marcescens_.
SKIN INFECTIONS:
Caused
by
_Staphylococcus _
_aureus_
(penicillinase
and
non-penicillinase
producing),
_S. epidermidis_, group A streptococci, _ Escherichia coli_, _ Proteus
mirabilis_ and indole